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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: lenalidomide
Trade Name: Revlimid
Date Designated: 04/27/2009
Orphan Designation: Treatment of mantle cell lymphoma
Orphan Designation Status: Designated/Approved
Celgene Corporation
86 Morris Avenue
Summit, New Jersey 07901
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: lenalidomide
Trade Name: Revlimid
Marketing Approval Date: 06/05/2013
Approved Labeled Indication: Treatment of mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
Exclusivity End Date: 06/05/2020 
Exclusivity Protected Indication* :  Treatment of mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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